knowledge -WSS

knowledge

author：Wikipedia 2025-08-26 02:46:32 - browse：56

Patient treated with Impella in the heart. -- health tech coverage from STAT — Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software. Business Wire

The Food and Drug Administration is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed.

Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software. The FDA published a warning letter on Wednesday telling the company it should have submitted its software for approval before putting it on the market. The agency also took issue with Abiomed’s failure to report various problems with its heart pumps.

The letter comes a year after the Food and Drug Administration announced its intention to regulate more health software tools, sending the industry into an uproar.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Wildfire smoke exposes gaps in outdoor worker protections
Next article： Poland's lawmakers approve a divisive law on Russian influence

focus

WSS

Poland's lawmakers approve a divisive law on Russian influence

Penis shrinkage, a side effect of prostate cancer surgery, is temporary

Grandmother of French teen shot dead by police officer pleads with rioters to stop the violence

Typhoon Doksuri makes landfall in China after bringing deadly landslides to Philippines

5 wounded, 2 critically, in Michigan shopping center shooting

Drug cartel violence flares in western Mexico after vigilante leader's killing

focus

knowledge

focus

Alkermes shareholders re

What affirmative action's end means to a medical student

State Dept. review finds Biden bears some blame for Afghanistan failures

STAT wants to know your pick for a great summer read or listen

Alkermes shareholders re

5 wounded, 2 critically, in Michigan shopping center shooting

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Skip the lead apron during X

Novavax promises a turnaround & Lilly roils the obesity market

Security flaws in third

knowledge

STAT wants to know your pick for a great summer read or listen

Snowpack in the West is melting rapidly. Where will all that extra water go?

What AstraZeneca

A pollution tax on older cars can be extended to London's suburbs after a British court ruling

9 mass shootings over the weekend rock US cities, leaving 5 dead, 56 injured

Doctors increasingly discourage vaping amid mounting health concerns

knowledge

hotspot

entertainment

hotspot